BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 3041031 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-06478
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    July 23, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO INCREASING PAIN, ELEVATED METAL ION LEVELS, AND PSEUDOTUMOR AROUND THE HIP. MILKY-GRAY FLUID, METAL STAINED TISSUE AND SOFT TISSUE NECROSIS WERE ALSO NOTED INTEROPERATIVE,.

    Description of Event or Problem · 1

    **UPDATE**(B)(4) 2013 - LITIGATION RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM DISCOMFORT, SORENESS, MALAISE, AND SWELLING. ALSO ALLEGED IS IMMOBILIZATION AND BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND BONE SURROUNDING THE ACETABULUM AND SYSTEMIC INJURIES. PART/LOT INFORMATION WERE IDENTIFIED AND UPDATED. THE COMPLAINT AND ASSOCIATED MDR'S WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143821 ASR ACETABULAR CUPS 50 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2956107

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention